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Seno Medical’s market-ready Imagio OA/US Breast Imaging System launches at RSNA 2022

Press releases may be edited for formatting or style | November 28, 2022 Women's Health
[SAN ANTONIO, TX – November 27, 2022] Seno Medical, makers of the Imagio® Breast Imaging System - a revolutionary new modality in breast imaging - will officially launch the commercially available system at the annual RSNA Scientific Assembly and Annual Meeting starting November 27 through December 1 in Chicago (Booth 6120). Recently recognized with a Gold Edison award, a Gold Medical Design Excellence Award, and as a semifinalist in the Minnies 2022 competition for its medical innovation, Seno’s groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information about breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation.

In support of the launch at RSNA, Seno Medical will bring its category-defining Imagio® System to the doorsteps of clinicians and healthcare providers throughout the USA with its mobile education and demonstration tour, Imagio® OA/US Road Show - Scans Across America. The hands-on tour, which began this summer and is scheduling stops across the country throughout the coming year, enables on-site demonstrations of the Imagio® System.

The market-ready Imagio® System received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) in June of this year; it incorporates the latest in ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the opto-acoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio® ergonomic and truly disruptive for the marketplace with its novel technological advances.

Tom Umbel, President and CEO of Seno Medical, commented, “The time has come for the market to start adopting and using this groundbreaking new hybrid modality for breast imaging, and we are proud to be showcasing it at RSNA.”

Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the US healthcare system more than $2 billion per year.i Seno’s Imagio® technology could significantly reduce those costs with its non-invasive OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and hypoxia — Seno Medical has shown that the Imagio® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio® System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram®) to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto- acoustic imaging. Originally approved by the US FDA in January 2021, Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

Indication statement: The Imagio® system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

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